Embolism protection device, method for folding same, and molding device

Description

[0001] The invention relates to an embolic protection device according to the preamble of claim 1, which prevents unwanted macroscopic particles from entering one or more branches of a main vessel, such as the aortic arch, from a bloodstream. The invention also relates to a forming device for shaping the embolic protection device according to the invention, as well as a method for folding and unfolding the embolic protection device according to the invention using the forming device.

[0002] Cerebral embolism is a known complication in cardiac surgery and interventional cardiology. Particles can be dislodged during surgical or interventional procedures. They can enter the bloodstream and, particularly in the brain, trigger an embolism. In the case of a cerebral embolism, this can lead to a stroke or even be fatal.

[0003] Embolic protection devices are known, for example, from EP2859864 of the applicant. Furthermore, WO 2015 / 177322 A1 discloses an embolic protection device for insertion into an aortic arch.

[0004] The object of the present invention is to provide an improved embolism protection device that prevents unwanted macroscopic particles from entering one or more vascular branches of a main vessel in a simple manner.

[0005] The problem is solved according to the invention by the features of the independent claims. Advantageous embodiments of the invention are described in the dependent claims.

[0006] A first aspect of the invention relates to an embolic protection device for delivery into an aortic arch, comprising a filter unit, a frame, and a delivery unit, wherein the filter unit is arranged on the frame. The frame has a proximal region comprising a proximal shape, which is arranged in an interior region of the frame and is connected to the delivery unit, wherein the proximal shape comprises a first part and a second part, the second part being formed at one end of the first part. The interior region of the frame includes both the plane spanned by the frame and the region above or below this plane.

[0007] The embolic protection device according to the invention advantageously provides a device characterized in that the connection between the proximal form and the delivery unit creates a spring mechanism which ensures that the embolic protection device is pressed against the vessel wall in the aorta, essentially in the distal region, towards the head vessels. The embolic protection device essentially deflects unwanted macroscopic particles.

[0008] The proximal portion is positioned anterior to the orifice of the left subclavian artery by retracting the delivery unit. This ensures a stable position within the aortic arch. Alternatively, the embolic protection device can also be inserted via the right subclavian artery. In this case, the proximal portion is positioned anterior to the orifice of the brachiocephalic trunk by retracting the delivery unit.

[0009] The spring mechanism is primarily defined by the geometry of the proximal form. Preferably, the first part of the proximal form is arranged below the plane of the frame, particularly within the frame. The first part is advantageously arc-shaped. The second part of the proximal form is preferably arranged above the frame, particularly within the frame. The second part is advantageously straight. The first and second parts preferably form an angle with each other and / or with the plane of the frame. In other words, at least the first and / or the second part can be arranged above or below the plane of the frame, with the angle between the first part and the plane of the frame being different from the angle between the second part and the plane of the frame, such that the first and second parts form an angle.

[0010] The feed unit can apply tension to the proximal form, so that the spring action is transferred via the proximal form to the entire frame of the embolic protection device. This tension transfer causes the distal part of the frame to fold upwards.

[0011] The frame of the embolic protection device spans a two-dimensional plane and transitions into a proximal form in its proximal region, which can advantageously project downwards or upwards from this plane. The proximal form, located inside the frame and connected to the delivery unit, creates the spring mechanism that ensures the frame with the filter unit can be fixed over one or more blood vessels in such a way that they are protected or covered. Radial forces act when the filter unit is deployed. The positioning of the embolic protection device is achieved by the spring mechanism and the delivery unit. Furthermore, haptic feedback is provided when positioning the embolic protection device, or resistance is felt when retracting the delivery unit, thus allowing verification of the correct position of the embolic protection device.In particular, this also covers and protects the head vessel through which the embolic protection device is inserted.

[0012] Due to the geometry of the frame, in particular the proximal shape and / or the distal shape, the embolic protection device adapts flexibly to the anatomical conditions in the aortic arch, regardless of the access route, and provides complete coverage of all head vessels.

[0013] Advantageously, the first and second parts of the proximal form are arranged inside the frame. In particular, the connection between the proximal form and the delivery unit is located inside the frame, ensuring coverage of the access vessel. In other words, the proximal section of the frame or filter unit covers the ostium of the access vessel and extends well beyond it. Simultaneously, the proximal section of the frame or filter unit rests against the aortic wall. This ensures coverage of the access vessel, especially when the embolic protection device is positioned in the aortic arch.

[0014] The embolic protection device according to the invention, in particular the frame and the filter unit arranged thereon, can be completely folded and unfolded. In the folded state, the embolic protection device is preferably dimensioned such that it has a diameter of substantially 1.4–2.2 mm, particularly 1.7–1.8 mm. The embolic protection device has three states: an unfolded state in which the embolic protection device is in its basic form (basic state), a folded state, for example in a catheter (folded state), and an unfolded state (placement state) when the embolic protection device is used according to its intended purpose, for example in the aortic arch in the final position. The final position in the aortic arch is hereinafter also referred to as the placement position.

[0015] The geometric form of the three states differs. During transport and preparation for implantation, the embolic protection device is in its basic form, as shown, for example, in the figures. Through mechanical deformation, the basic form is transformed into the folded state. The reversibly deformable material of the frame, for example, a superelastic nitinol wire, can be deformed so that the embolic protection device can be inserted into a catheter. The embolic protection device stretches along its length, transitioning into a straight or elongated form by folding the distal and proximal forms into an outer area of ​​the frame. The associated change in length is due to the reduction in width. The folded frame, i.e.,The two sides of the frame, outside the distal and / or proximal shapes, lie parallel to each other within the catheter from tip to end, i.e., from the distal to the proximal shape. The specially attached filter unit can follow this mechanical deformation and settles into the space between the catheter and the wire. The frame, made of nitinol, exhibits a shape memory effect.

[0016] In its placement position within the aortic arch, the geometry of the embolic protection device's frame flexibly adapts to the aortic wall, lying in a gentle arc, following the curvature of the aorta, anterior to the origins of the head vessels. Upon exiting the catheter, both the distal and proximal forms fold back into their original shape, thus enabling atraumatic positioning of the frame against the aortic wall. The special shape of the folded distal and proximal forms avoids sharp edges or corners. Radial forces generated by the frame's shape memory effect tension the filter surface. Additional stabilization of the frame is achieved through the physiological conditions within the aorta, as the blood flow, due to the filter's surface resistance, further presses the embolic protection device's frame into its placement position.

[0017] The frame material is preferably nitinol. The frame can be a wire or a hollow wire with a platinum / platinum-iridium / tantalum wire embedded in its cavity, the cavity being almost completely filled. Alternatively, the frame can be made of DFT wire, for example from Fort Wayne Metals, or a wire with a permanently bonded platinum / tantalum core. These examples of frame material have the advantage that the frame is radiopaque.

[0018] The filter unit comprises a selectively permeable filter material, preventing, for example, unwanted macroscopic particles from the bloodstream from entering one or more branches of a main vessel, such as the aortic arch. The filter material can be various materials, such as plastics or metallic materials like nitinol. Depending on the material used, it can be woven, cast, laser-cut, or stamped. Preferably, the filter material is a woven polyamide membrane. The filter material preferably has a pore size of 40–150 µm and an open porosity of 35–60%, ensuring both good protection against unwanted particles and good blood permeability. The filter material can have rectangular or square perforated surfaces. The thickness of the filter material is preferably 20–120 µm.

[0019] The feed unit is a tube made of wound stainless steel wire, although other materials can also be used. The feed unit is kink-resistant and serves to transmit rotational and force when positioning the embolic protection device. Advantageously, the feed unit is 120-250 cm long with a diameter of 1.5 mm and has an outer coating made of plastic (Pebax coating, polyethylene (PE), polytetrafluoroethylene (PTFE), polyamide (PA)).

[0020] The length of the embolic protection device is advantageously 50 to 100 mm. The width of the embolic protection device is advantageously 15 to 45 mm.

[0021] In an advantageous further development of the embolic protection device, the first part of the proximal shape has a first angle relative to the plane of the frame, and the second part has a second angle relative to the first part of the proximal shape. Advantageously, the first and second parts of the proximal shape are coaxially aligned at the junction between them and form the spring mechanism. The angles are changed by the feed unit, thus fixing the embolic protection device in its placement position in the aortic arch. The first part of the proximal shape has an angle of approximately 25 to 50 degrees, preferably 30 degrees, downwards to the two-dimensional plane of the frame, measured from the first part to the plane. The first part is straight or curved and preferably has a length of 0.5 to 2.5 cm. The second part, preferably straight, is arranged at the end of the first part.The second part forms a second angle with the first part, preferably of 80 to 115 degrees, measured from the second part to the first part. When measured to the two-dimensional plane of the frame, the second angle is essentially 110 to 145 degrees, measured from the second part to the plane. The length of the second part is preferably essentially 1 to 5 cm. This geometric shape of the proximal form ensures that, in its placed state, the proximal form has a geometry adapted to the anatomy.

[0022] Another advantageous development involves the proximal form comprising two ends of the frame that extend parallel to each other within the frame. This results in increased frame stability in both the longitudinal and transverse directions. In further developments of the embolic protection device, the two ends are connected to the feed unit by means of an adhesive bond. The wire ends are thus not freely accessible. Further developments are also possible in which the proximal form comprises only one end of the frame, with the other end of the frame being connected, for example, to the feed device.

[0023] In advantageous further developments, the frame is provided with a distal area comprising a distal shape located within the frame. Advantageously, the tip of the distal shape is coated with an atraumatic material (e.g., membrane material, polymer, rubber, or hard adhesive) to provide atraumatic protection. This material can advantageously be shaped like a droplet.

[0024] In another advantageous development, the distal form is characterized by a constriction directed towards the interior of the frame. This constriction serves as an attachment point for the filter unit. It also acts as a positioning aid within the aorta, as it is equipped with radiopaque markers and can be advantageously used to indicate the frame's orientation within the catheter. Furthermore, the distal form, located within the interior of the frame, advantageously serves as a positioning aid when inserting the embolic protection device into a catheter using a forming device. The distal form can be hooked onto or within the forming device and folded in the opposite direction to its original orientation. In other words, the distal form can be folded outwards, i.e., into an area outside the interior of the frame.This has the advantage that, when the frame is inserted through, for example, a catheter, it can be positioned within the catheter in a space-saving manner. Folding the distal form transfers torsional forces to the frame, causing it to fold back into the interior of the frame when the embolic protection device is deployed in the aortic arch.

[0025] According to the invention, the connection between the frame and the filter unit is an adhesive tunnel connection. The adhesive tunnel connection is designed as an enveloping polymer form around the frame. In other words, the adhesive encases the frame in a tubular or cylindrical form. The polymer form creates an adhesive tunnel in which the frame is arranged and can move relative to it. Advantageously, the connection between the adhesive tunnel and the filter unit can also be mechanically stable. The separation of the filter unit from the frame creates flexibility in the distal and proximal areas, which allows or at least facilitates the folding of these areas when the embolic protection device is folded or unfolded.

[0026] In another advantageous development, the filter unit is connected to the frame outside the proximal and / or distal area. This connection is mechanically stable, meaning there is no relative movement between the adhesive bond and the frame. Advantageously, the connection is designed as a flexible joint. For example, the connection can be an adhesive bond, a positive fit, a weld, or a sewn joint. The adhesive tunnel enables a stable and flexible connection, even or especially during the folding or unfolding of the embolic protection device.

[0027] In a further advantageous embodiment, the filter unit is connected to the frame in the distal area essentially up to the constriction. This prevents the filter unit from unintentionally folding over below the frame. The connection can extend to the beginning of the constriction.

[0028] In another advantageous further development, the filter unit in the proximal area is essentially connected to the frame up to the first part of the proximal form. The connection can extend to the beginning of the first part.

[0029] In another advantageous development, the filter unit is flexibly connected to the frame in the distal and proximal areas. This allows relative movement between the frame and the filter unit. This ensures that the frame is movably connected to the filter unit in the proximal and distal areas. In contrast, the frame is rigidly connected to the filter unit in the remaining area.

[0030] According to the invention, this connection is an adhesive tunnel connection, preferably designed as an enveloping polymer form around the frame. For an adhesive tunnel connection, the frame is placed in an adhesive. As the adhesive dries, it shifts and forms a polymer shape on the filter unit (like a tube). Changes in the geometry of the embolic protection device, particularly of the frame, for example when folding or unfolding the frame or the filter unit, can thus be easily accommodated, preventing distortion or, in extreme cases, damage to the embolic protection device.

[0031] Preferably, the frame is connected to the filter unit under preload. For example, the frame can be slightly compressed before being connected to the filter unit to maintain preload. The connection between the filter material and the frame is preferably designed such that the frame exerts a preload on the filter unit both in its initial state and when installed.

[0032] Advantageously, the filter unit is glued to the underside of the frame. This results in a smooth surface facing the bloodstream.

[0033] In an advantageous further development, the edge of the filter unit is sealed before being attached to the frame in order to prevent changes in shape during application and to enable the least traumatic interaction possible with the aortic wall.

[0034] In another advantageous embodiment, the filter unit is provided with a projection extending beyond the frame. Preferably, this projection extends beyond the proximal and / or distal region. The projection of the filter unit beyond the frame, respectively, is advantageously between 0.5 and 2.0 mm wide, forming a sealing lip against the vessel wall when the frame is positioned in the aortic arch during placement. This sealing lip promotes atraumatic placement of the frame and ensures its dimensional stability. Additionally, this sealing lip seals against the aortic wall during placement, thus preventing leakage flow in the lateral region of the embolic protection device, similar to a valve.

[0035] The overlap is advantageously sealed, resulting in a smooth finish for the filter material. This also facilitates atraumatic placement of the frame.

[0036] In another advantageous development, the filter unit is folded over the frame from the underside to the top in the proximal and / or distal region. The filter unit thus extends beyond the outer edge of the frame. This folding over the filter unit improves its fixation to the frame, ensuring complete coverage of all head vessels when the embolic protection device is positioned in the aortic arch. The filter unit forms a double layer in the proximal and / or distal region, thereby increasing its filtration efficiency.

[0037] In another advantageous development, the filter unit is attached to the distal and / or proximal form using a thread, yarn, or wire. This connection can also be sealed to ensure dimensional stability. Furthermore, sealing the connection renders this area atraumatic.

[0038] In a further advantageous development, the filter unit is attached to the distal form by means of an adhesive bond. This bonding can be achieved using a hard adhesive. Due to the adhesive bond, the frame has an atraumatic tip in the distal area, so that in the event of contact with, for example, the aortic wall, the latter is protected from injury.

[0039] Advantageously, the filter unit is attached to the proximal section by means of a helix. The helix is ​​made of stainless steel wire, which preferably wraps around the ends of the frame in a spiral pattern. The helix serves to stabilize the connection between the filter unit and the feed unit. Furthermore, the helix design facilitates the shape change during the folding and unfolding of the embolic protection device.

[0040] To further improve the embolic protection device, an advantageous further development provides that the filter unit comprises a fiber material, the fibers being oriented at an angle of substantially 45 degrees to a longitudinal axis of the frame. The fiber material consists of a woven membrane, thus ensuring increased flexibility in both the longitudinal and transverse directions of the frame. The longitudinal direction of the frame extends from the proximal to the distal region and is preferably the centerline of the frame. Preferably, the inclination of the fibers forms an angle of 45 ± 10 degrees to the longitudinal axis of the frame.

[0041] In another advantageous embodiment, the proximal form is connected to the feed unit, with the two ends of the frame being wrapped by a wire whose ends are arranged parallel to the ends of the frame. The connection of the proximal form of the frame to the feed unit is preferably achieved via an adhesive bond. The ends of the frame are inserted into an open lumen of the feed unit and bonded there. The wire that wraps around and thereby secures the ends of the frame is preferably a stainless steel wire and serves to further stabilize the ends of the frame. The ends of the wrapped stainless steel wire lie parallel to the ends of the frame wire and are preferably bonded together in the feed unit. The transition from the frame wire to the feed unit, as well as the wrapped stainless steel wire, are preferably flexibly sealed, e.g., with a flexible sealant.with a polymer blend to enable a smooth surface and a uniform transition.

[0042] Preferably, the frame of the embolic protection device has a basic shape that is oval. The oval shape is adapted to the native shape of the aortic arch roof, thus enabling reliable coverage of all three head vessels. The upper part of the aortic arch at this point is shaped like, for example, the inside of an inverted oval bowl. By inserting an oval shape, a form-fit is achieved. Preferably, the oval shape tapers towards the proximal end. In other words, the cross-section through the aorta at the point where the embolic protection device is placed is oval, so that the oval shape of the frame advantageously adapts to the physiological shape at this point.

[0043] A second aspect of the invention relates to a forming device for shaping the embolic protection device according to the invention. The embolic protection device has all or at least some of the aforementioned features – these are not individually described again here. The shaping is carried out to feed the embolic protection device into a catheter, whereby the frame with the filter unit of the embolic protection device arranged thereon is transformed from an expanded state to a stretched state. The forming device has two sections that meet at a very narrow cross-section. The sections are each preferably funnel-shaped. The distal section is preferably designed as a flat or round funnel and serves to draw in the embolic protection device according to the invention. The proximal section is preferably designed as a circular funnel and serves to receive a substantially circular tube, e.g.a commercially available introducer sheath or catheter. The forming device is a tool with a geometry that allows the embolic protection device, in particular its frame, to be reshaped so that its diameter in the folded state is preferably substantially 1.4–2.0 mm, and more specifically 1.7–1.8 mm. The forming device ensures that the embolic protection device can be easily inserted into a substantially circular tube, such as a commercially available introducer sheath or catheter.

[0044] In a further development, the preferred flat or round opening of the forming device is designed such that the proximal and / or a distal form of the frame of the embolic protection device is folded outwards. This ensures, among other things, correct and damage-free insertion of the embolic protection device, for example, into a catheter. In other words, the proximal and / or distal form, which in the basic shape of the embolic protection device extends towards the inside of the frame, is folded in the opposite direction, i.e., outwards, by the flat or round opening.

[0045] A third aspect of the invention relates to a method for folding the embolic protection device according to the invention using the forming device. The embolic protection device has all or at least some of the aforementioned features – these will not be repeated individually here. The method comprises the following steps: Sliding the frame of the embolic protection device in front of the flat or round opening of the molding device, whereby the feed unit is passed through the molding device; drawing the proximal shape into the molding device, whereby the proximal shape is folded outwards; hooking the distal shape over the outer edge of the distal part of the molding device, whereby by further pulling the distal shape is folded outwards and drawn into the molding device.

[0046] In a further development of the method, it is advantageously provided that, as the frame is drawn into the mold, it is compressed and elongated. Due to the tapered shape of the distal section of the mold, the frame is compressed from both sides, so that it has an elongated shape when it exits the narrowest cross-section of the mold.

[0047] In a further development of the procedure, it is advantageously provided that the embolic protection device is inserted from the aforementioned tube, which contains the folded embolic protection device and can, for example, be a commercially available introducer sheath, into a catheter pre-positioned in the aortic arch. A hemostasis valve at the proximal end of the catheter serves to receive and fix the tube and simultaneously minimizes blood loss during placement. By advancing the delivery unit, the embolic protection device is then advanced from the tube into the catheter. Once the frame is completely inside the catheter, the tube can be removed and withdrawn via the delivery unit. The embolic protection device can then be advanced beyond the distal end of the catheter into the aortic arch by advancing the delivery unit.

[0048] In another further development of the procedure, it is advantageously provided that the embolic protection device is inserted from the aforementioned tube, which can be, for example, a commercially available catheter, into a sheath pre-positioned in the aortic arch. By advancing the tube through the sheath, the embolic protection device can be pushed within the tube to the distal end of the sheath in the aortic arch.

[0049] In all further developments of the embolic protection device according to the invention, it is provided that the folded proximal form transmits a preload to the frame which is essentially the same as the tension resulting from the straightening of the bent proximal form.

[0050] Furthermore, a method for unfolding the embolic protection device from a catheter containing it is also provided. The invention also encompasses the fact that the embolic protection device can be accommodated in an elongated, cylindrical, or catheter-like device, for example, by folding the embolic protection device. When unfolding the embolic protection device from the catheter, it is first pushed out until the distal portion of the frame has exited the catheter. By further advancing the embolic protection device from the catheter, the distal portion is pushed out and folds back into the interior of the frame. This folding of the distal portion returns the frame in its distal region to the pre-tensioned state it was in before the embolic protection device was folded.Folding the distal shape serves as an orientation aid and allows the frame of the embolic protection device to be reshaped, enabling its insertion into almost any catheter. Furthermore, folding the distal shape is atraumatic.

[0051] The delivery unit may have two markings on its proximal area, the first indicating, when the embolic protection device is subsequently positioned by the guide catheter, that the distal form is located directly in front of the catheter's exit orifice, and the second marking indicating that the frame has completely left the catheter.

[0052] In a further advantageous development, the direction of the frame is indicated by one or more markers. These markers can be radiopaque. The markers can be positioned, in particular, in the distal region of the frame. The distal region indicates the direction of the frame's advancement from the catheter. This has the advantage that the exact position of the frame, its advancement direction, and its placement position can be precisely determined.

[0053] Further details of the invention can be found in the exemplary embodiments described below with reference to the figures. All details of the invention listed below are not limited to the specified exemplary embodiments, but can also occur individually, selectively together, or in their entirety in other exemplary embodiments.

[0054] They show: Figure 1 : Embolism protection device according to the invention; Figure 2: Top view of the frame of the embolism protection device Figure 1 ; Figure 3 : Side view of the frame from Figure 2 ; Figure 4 : perspective view of the proximal area of ​​the frame from Figure 2 ; Figure 5A : Frame with a configuration of radiopaque markers; Figure 5B : Frame with a further configuration of radiopaque markers; Figure 6 : Connection of a proximal form according to the invention with the feeding device; Figure 7 : Cross-sectional view of an adhesive tunnel with frame, filter unit and seal; Figure 8 : Top view of a frame with a filter unit attached to it; Figure 9 : distal filter unit made of Figure 8 ; Figure 10 : Top view of a proximal form with an arranged filter unit; Figure 11 : perspective view of the proximal form from Figure 10 ; Figure 12 : Top view of a distal formwork with an arranged filter unit; Figure 13: perspective view of the distal form from Figure 12 ; Figure 14 : View of a folded embolic protection device in a catheter; Figure 15A-F : Transformation of a frame of an embolism protection device according to the invention from a folded state into an unfolded state; Figure 16 : schematic view of the deployed state of the embolic protection device after exiting a catheter; Figure 17 : Procedure for the deployment of an embolic protection device after exiting the catheter in an aortic arch; Figure 18 : Covering of the head vessel origins in the aorta by the embolic protection device after the catheter leaves the body, as described in Figure 17 ; Figure 19 : Forming device for forming an embolism protection device according to the invention; Figure 20 : perspective view of the mold from Figure 19 ; Figure 21 : Method for folding the embolic protection device according to the invention using a forming device.

[0055] In Figure 1 An embolic protection device 1 according to the invention is shown. The embolic protection device 1 comprises a frame 5 on which a filter unit 3 is arranged. The frame 5 is connected to a feed unit 7. The length of the frame 5 is advantageously 50 to 100 mm. The width of the frame 5 is advantageously 15 to 45 mm. In this embodiment, the frame 5 consists of a single, continuously bent wire. However, the described properties and advantages of the embolic protection device also apply to other embodiments.

[0056] Frame 5 has a two-dimensional and a three-dimensional area. The two-dimensional area, i.e., the plane spanned by the frame, has an oval shape that transitions into a proximal shape 11 and a distal shape 4 at the distal and proximal areas 2 and 9, respectively. The proximal shape 11 and the distal shape 4 constitute the three-dimensional area of ​​frame 5, while the remaining area of ​​frame 5 forms the two-dimensional area, i.e., the oval shape. The embolic protection device 1 is shown in its basic form.

[0057] Figure 2 shows a top view of frame 5 of the embolic protection device 1. Figure 1The proximal region 9 of the frame 5 is the one that terminates in the open ends 17, 19 of the frame 5, in this embodiment the ends of the wire. The proximal region 9, and thus also the proximal shape 11, is defined by the two loose ends 17, 19 of the frame 5 or wire used. The proximal shape 11 has a first part 13 and a second part 15, which in this embodiment are formed by the parallel ends 17, 19. In the distal region 2, the frame 5 transitions into a distal shape 4. The distal shape 4 has a constriction 12 of the wire into the interior of the frame 5, or in other words, into the interior of the oval two-dimensional region, of approximately 1-3 cm.

[0058] In this embodiment, the constriction 12 is a loop with a head diameter of approximately 1–1.8 mm and the wire, which is otherwise parallel to each other. The loop and the parallel wire are located in the same two-dimensional plane of the frame 5.

[0059] Figure 3 shows a side view of frame 5 from Figure 2The proximal form 11 extends parallel to the ends of the frame 17, 19, as does the frame in the distal form 4, into the interior of the frame 5. The first part 13 of the proximal form has a first angle W1 of preferably 25 to 50 degrees downwards with respect to the two-dimensional plane of the frame 5, the angle being measured from the first part 13 towards the plane of the frame. After a length of preferably 0.5 to 2.5 cm of the first part 13, a second part 15 is arranged at the end of the first part 13 at a second angle W2 of preferably 110 to 145 degrees upwards from the two-dimensional plane of the frame 5, the angle being measured from the second part 15 towards the plane of the frame. The length of the second part 15 is 1 to 5 cm. The lengths of the first and second parts 13, 15 as well as their angles to the plane of the frame 5 can also be chosen to be larger or smaller according to the requirements of the embolic protection device.

[0060] The first and second parts 13, 15 form the proximal shape 11, which is arranged in an interior area of ​​the frame 5, with the proximal shape 11 extending above and below the plane of the frame 5. This geometric shape of the proximal shape 11 prestresses the frame 5 and simultaneously stabilizes it in the longitudinal and transverse directions.

[0061] It is possible that the first part 13 extends into the plane of the frame 5, so that the angle W1 is equal to 0 degrees and only the second part 15 is inclined to the plane of the frame 5 by a second angle W2.

[0062] The distal form 4, which includes the constriction 12, lies in the two-dimensional plane of the frame 5.

[0063] Figure 4 shows a perspective view of the proximal area 9 of the frame. Figure 2The proximal form 11 comprises the first part 13, which is bent at a first angle W1 to the plane of the frame 5, the second part 15, which is bent at a second angle W2 to the plane of the frame 5, and the two ends 17, 19 of the frame 5. Both the first part 13 and the second part 15 of the proximal form 11 each have two frame wires.

[0064] Figures 5A and 5BFigure 5 shows a frame 5 with a configuration of radiopaque markers 20. The radiopaque markers 20 are positioned at key locations on the frame 5 for radiopaque visibility. For example, radiopaque markers 20 are located in the region of the constriction 12 and on the frame in the distal region 2, allowing the precise position of the tip of the frame 5 to be determined. Furthermore, radiopaque markers 20 are located on the frame 5 outside the distal or proximal regions 2, 9. The distance between the markers 20 indicates the stage of folding or unfolding of the embolic protection device 1. The radiopaque markers 20 also allow the precise position of the embolic protection device 1 within the aortic arch to be determined.

[0065] The radiopaque markers can be platinum / iridium sleeves that are slid or snapped onto the frame. The sleeves have a slightly larger inner diameter than frame 5, a wall thickness of approximately 50-100 µm, and are fixed with an adhesive.

[0066] In the Figures 5A, 5B These are just a few examples of how to position radiopaque markers. There are also various other ways to apply radiopaque markers depending on the desired outcome.

[0067] Figure 6 Figure 1 shows a connection between a proximal form 11 according to the invention and a feeding device 7 according to the invention, wherein the ends 17, 19 of the frame 5 of the proximal form 11 are shown in the drawing. The ends 17, 19 are also simultaneously the end of the second part 15 of the proximal form 11.

[0068] In this embodiment, the feed unit 7 comprises a stainless steel helix and has a sealed casing. In this embodiment, the outer diameter of the feed unit 7 is 1.5 mm and its open lumen has a diameter of 0.8 mm. The overall length of the feed unit 7 is 150 cm. Other dimensions for the feed unit 7 are possible.

[0069] The proximal form 11 of the frame 5 is connected to the feed unit 7 via an adhesive unit 8, for example, polyurethane adhesive. The wire ends 17, 19 of the proximal form 11 are inserted into the open inner lumen of the feed unit 7 and glued in place. For clarity, the adhesive unit 8 is shown hatched in the figure.

[0070] For additional stabilization, the wire ends 17, 19, i.e., the second part 15 of the proximal form 11, are fixed by means of a wrapped stainless steel wire 6. The wire ends 10 of the wrapped stainless steel wire 6 lie parallel to the ends 17, 19 of the frame 5 and are bonded within the feed unit 7. The transition from the proximal form 11 to the feed unit 7, as well as the wrapped stainless steel wire 6, are also coated with polyurethane to ensure a smooth surface and a uniform transition.

[0071] Figure 7 Figure 1 shows an enlarged cross-sectional view of the connection between frame 5 and filter unit 3. The connection is designed as an enveloping polymer form around frame 5. The polymer form creates an adhesive tunnel 41 in which frame 5 is positioned on filter unit 3. The seal 42 is shown at the outer edge of filter unit 3 in this figure.

[0072] Figure 8Figure 5 shows a top view of a frame 5 with a filter unit 3 attached to it. The length of the frame 5 is advantageously 50 to 100 mm. The width of the frame 5 is advantageously 15 to 45 mm. In this embodiment, the filter unit 3 is fixed to the frame 5 by means of an adhesive or a polyurethane-based adhesive. The bond runs continuously along the outer part of the frame 5. The parts of the frame 5 in the proximal and distal regions, which are folded inwards in the basic form, are not bonded to the filter unit 3. The filter unit 3 is bonded to the underside of the frame 5 so that the surface of the filter unit 3 faces the central blood flow when the frame 5 is positioned in its placement position in the aortic arch.

[0073] The frame 5, in this embodiment made of Nitinol, is bonded to the filter unit 3 under preload to achieve improved clamping force of the frame 5. This reduces the width of the frame 5 from 35-45 mm to 25-35 mm.

[0074] The filter unit 3 projects with a protrusion 14 of approximately 1 mm beyond the frame 5 onto its upper surface and is folded or folded over from the underside over the frame 5 to the upper surface in the distal and proximal regions 2, 9 of the frame 5. The protrusion 14 of the attached filter unit 3 beyond the outer edge of the frame 5 has the additional function of a flexible sealing lip towards the aortic wall when the embolic protection device 1 is in its placement position in the aortic arch.

[0075] The folded section of filter unit 3 comprises a proximal filter unit 21 and a distal filter unit 22. The proximal and distal filter units 21, 22 are not fixed to the frame with adhesive, thus facilitating the desired deformation during the intended passage of a catheter. The proximal filter unit 21, together with the second part 15 of the proximal form 11, is fixed under the wrapped stainless steel wire 6 and sealed in this area; see also the illustration in Figure 7 .

[0076] The distal filter unit 22 is attached to the constriction 12 of the distal form 4. The distal filter unit 22 extends beyond the constriction 12 further into the interior of the frame 5, approximately 2-5 mm, and is additionally flexibly sealed.

[0077] The fibers of filter unit 3 are oriented at a 45° angle to the centerline of frame 5 from beginning to end. This allows filter unit 3 to expand more effectively in the longitudinal direction, while providing stability in the transverse direction. The outer edges of the overhangs 14, 21, and 22 are additionally sealed.

[0078] Figure 9 shows an end area of ​​the distal filter unit 22 of the filter unit 3 Figure 8 . The distal filter unit 22 is cut in such a way that it not only extends approximately 2 mm beyond the constriction 12, but also widens again behind the constriction 12 and takes on the shape of a flag 23.

[0079] This flag 23 is rolled up. The ends of the thread used for fixation are enclosed inside the flag 23. Adhesive secures the distal filter unit 23 against unrolling. The diameter of the rolled-up distal filter unit 22 is less than 1.6 mm. In addition to fixing the distal filter unit 23, this also creates an additional protective cushion between frame 5 and the aortic wall to prevent injury.

[0080] Figure 10Figure 21 shows a top view of a proximal form 11 with an attached filter unit 3. The proximal filter unit 21 is folded around the frame 5 towards the top. In this embodiment, both the first part 13 and the second part 15 of the proximal form 11 are wrapped with a stainless steel wire 6 (for better illustration of the stainless steel wire, the first and second parts 13 and 15 of the proximal form are not shown). The first part 13 has a first angle W1 to the plane of the frame 5, and the second part 15 is bent at a second angle W2 to the plane of the frame 5.

[0081] Figure 11 shows perspective view of proximal form 11 from Figure 10 .

[0082] Figure 12Figure 1 shows a top view of a distal form 4 with an arranged filter unit 3, in particular a distal filter unit 22. The distal filter unit 22 is attached to the constriction 12 of the distal form 4 by means of a thread 43, which in other embodiments may also be a yarn or wire, and projects into the interior of the frame 5.

[0083] Figure 13 shows a top view of a proximal form 11 with an attached filter unit 3. The flag 23 is rolled up, with a thread used to fix it, as in Figure 9 as described and not repeated here.

[0084] Figure 14 Figure 1 shows a folded embolic protection device 1 in a catheter 25. The embolic protection device 1 is in a folded state. By mechanical deformation, the basic shape of the embolic protection device, as shown for example in the Figures 1 to 13The reversibly deformable material of the frame 5, for example a superelastic nitinol wire, can be deformed so that the embolic protection device 1 can be inserted into a catheter 25. The embolic protection device 1 stretches along its length. Both the distal form 4 and the proximal form 11 are folded into an outer area of ​​the frame 5.

[0085] By folding over the distal form 4 and the proximal form 11, the frame 5 transitions into a straight or elongated shape. The resulting change in length is due to the reduction in the width of the frame 5. The folded frame 5, i.e., the two sides of the frame outside the distal form 4 and / or proximal form 11, lie parallel to each other within the catheter 25. The filter unit 3 can follow this mechanical deformation and settles into the space between the catheter 25 and the frame 5. In this elongated form, the embolic protection device can be inserted into a catheter with, for example, an inner diameter of 1.7 mm.

[0086] Figure 15A-F shows a transformation of a frame 5 of an embolic protection device 1 according to the invention from a folded state to an unfolded state.

[0087] When positioning the embolic protection device from a catheter 25, for example into the aortic arch, the embolic protection device 1, in particular the frame 5 with the filter unit 3 arranged on it, is pushed out of the catheter 25. This is described in the Figures 15A-F shown.

[0088] Frame 5, which is made of reversibly deformable material, attempts to return to its original basic shape, as for example in Figure 1 shown, to be resumed. The filter unit 3 arranged on the frame 5 follows the transformation. Due to the advancement of the distal form 4, which is folded forward in the catheter 25, it folds back halfway towards its originally intended position upon exiting the catheter 25, after approximately 1-2 cm of advancement, cf. Figure 15AThe direction of the distal shape 4 indicates the position of the embolic protection device 1 inside the catheter 25. Radiopaque markers that can be attached to the distal shape 4 allow its position to be identified. The pointing direction of the distal shape 4 indicates the upper side of the embolic protection device 1. By rotating the catheter 25, the placement position, for example in the aortic arch, can be adjusted.

[0089] Since the constriction 12 in the distal region of the embolic protection device 1, i.e., the distal form 4, folds over immediately after exiting the catheter 25, compare Figure 15A-B The risk of potential damage to the vessel wall is minimized by further advancement of the embolic protection device 1. Additionally, the frame 5 at the distal form 4 is wrapped with atraumatic material which has a protrusion of approximately 1-2 mm and thus also counteracts potential injuries.

[0090] As the tube progresses into the aortic arch, frame 5 unfolds further until it is fully open. This is seen, for example, in the Figures 15C-F visible. Figure 15D This shows the same state of development as Figure 15C from a side view, whereby Figure 15C The figure shows the unfolded state from a top-down view. The distal form 4, now almost completely folded back in, the unfolding frame 5, and the unfolding filter unit 3 are shown.

[0091] In its fully unfolded state, the frame 5 is unfolded and the filter unit 3 is stretched over the frame 5. Figure 15E Figure 1 shows the fully unfolded frame or the unfolded embolic protection device 1 from a top-down view. Figure 15F from a lateral viewpoint. The effect of the spring mechanism through the proximal form 11 is evident from the transition of Figure 15C to Figure 15Eor Figure 15D to Figure 15F visible.

[0092] Figure 16 Figure 1 schematically shows the deployed state of the embolic protection device 1 after it exits a catheter 25. Due to the special geometry of the proximal form 11 up to the transition to the delivery unit 3, a preload is applied to the frame 5 to the same extent as the pre-bent proximal form 11 straightens. The figure shows two different states of the deployed state. The position of the filter unit is identical in both representations. The position of the first and second parts 13, 15, which are connected to the delivery unit (not shown), is shown in both the relaxed and the tensioned states. This results in a spring function, which will be explained in more detail below.

[0093] Once the embolic protection device 1 is correctly positioned, for example in the aortic arch, the transmitted tension of the proximal form 11 presses the distal form 4 against the aortic wall, thus allowing stable fixation against the blood flow. Figure 16 This is indicated sketchily by the thick, short arrow on the distal form 4. The proximal form 11 follows a movement represented by the thin, curved arrow. Without the resistance of the aortic wall, the frame 5 would follow the indicated folding direction – in Figure 16 the curved thin arrow - as for example in Figure 15E-F shown. As in Figure 16As shown, the proximal form 11 transitions into a form in which the first part 13 has a first angle W1 of 25 to 50 degrees above the plane of the frame, measured from the plane towards the first part 13, and the second part 15 has an angle W2 of 30 to 110 degrees above the plane of the frame, measured from the second part 15 towards the plane. The specified angle values ​​depend on the aortic geometry and are only examples.

[0094] Figure 17Figure 1 shows a schematic sequence of the deployment of an embolic protection device 1 after exiting a catheter 25 in an aortic arch. Figure (a) shows the insertion of the catheter 25 through the left subclavian artery, with the distal form 4 of the embolic protection device 1 at least partially folded back. Figures (b) to (d) show the further advancement and deployment of the embolic protection device 1, with the proximal form 11 also exiting the catheter in figure (d). Figure (e) shows the fully deployed embolic protection device 1 in its deployed state. The proximal region 9 of the frame 5 extends beyond the surface of the ostium of the left subclavian artery, thus achieving coverage by the embolic protection device 1 even across the access route.This protrusion simultaneously provides haptic feedback during positioning of the embolic protection device: by pulling on the delivery unit 7, slight resistance is felt as soon as the protrusion of the embolic protection device 1, more precisely of the frame 5, is correctly positioned in front of the orifice 27. The intended position is via the left subclavian artery into the aortic arch with the distal section 2 of the frame 5 pointing towards the heart valve.

[0095] The right subclavian artery can also be used as an alternative access route. The procedure is similar to that described in... Figure 16 shown, but in a mirrored version. Here, the distal area 2 of frame 5 points towards the descending aorta.

[0096] Figure 18 shows the covering of the head vessel origins 29 in the aorta by the embolic protection device 1 after exiting the catheter 25 as in Figure 17. Due to the special geometry of the frame 5, the embolic protection device 1 adapts flexibly to the anatomical conditions in the aortic arch, regardless of the access route, and provides complete coverage over all head vessels 29.

[0097] In its placement position in the aortic arch, the geometry of the frame 5 of the embolic protection device 1 adapts flexibly to the aortic wall and lies in a slight arc, following the curvature of the aorta, in front of the head vessel branches - see also Figure 17(e)Upon exiting the catheter 25, both the distal form 4 and the proximal form 11 fold back towards their original shape, i.e., towards the inner area of ​​the frame 5, thus enabling atraumatic positioning of the frame 5 against the aortic wall. This folding action avoids sharp edges or corners. Additional stabilization of the frame 5 is achieved through the physiological conditions in the aorta, as the blood flow further presses the frame 5 of the embolic protection device 1 into its placement position.

[0098] Figure 19Figure 1 shows a forming device 31 for forming an embolic protection device 1 according to the invention in various views. To simplify the forming of the embolic protection device from an unfolded state in its basic shape to an extended state, the embolic protection device is drawn into the distal section 33 of the forming device 31. The distal section 33 of the forming device 31 has a flat funnel with a flat opening 35 of approximately 25-40 mm in width and approximately 3-10 mm in height. Over the length of the distal section 33 of the forming device 31, which is approximately 60-80 mm, the opening surface of the front tapers to a circular, narrowest cross-section 39 with a diameter of approximately 1.7 mm. The proximal section 40 of the forming device 31 widens from the narrowest cross-section 39 to the round opening 37 to a diameter of approximately 1.8 to 5 mm over a length of 20 to 40 mm.This results in a total length of the forming device 31 of 80 to 120 mm.

[0099] Figure 20 shows a perspective view of the forming device 31 from Figure 19 .

[0100] Figure 21Figure 1 shows individual steps of the method for folding the embolic protection device according to the invention using a forming device 31, wherein the folded embolic protection device 1 is inserted into a substantially circular tube 38, e.g., a commercially available introducer sheath or a commercially available catheter (with an inner diameter of 1.8 to 2.5 mm). In step S1, the frame 5 of the embolic protection device 1, with the feed unit 7 leading, is inserted in front of the flat opening 35 of the forming device 31. The proximal end of the feed unit 7 is thereby passed through the distal end of the forming device 31. The substantially circular tube 38 is then pushed onto the feed unit 7 from the proximal side with its distal end until it reaches the round opening 37 of the forming device 31, with the feed unit 7 protruding from this tube 38.

[0101] In step S2, the hose 38 and the forming device 31 are connected to each other in the enlarged or conical round opening 37 of the forming device 31, for example by means of a plug connection. By pulling on the feed unit 7, the embolic protection device 1 is aligned.

[0102] By further pulling on the feed unit 7, in step S3 the proximal form 11 is folded over at the outer edge of the distal part 33 of the forming device 31, so that it is pulled straight through the forming device 31.

[0103] Further pulling on the feed unit 7 causes the distal form 4 to be pushed over the outer edge of the distal section 33 of the forming device 31 in step S4, whereby the distal form 4 hooks onto the edge and is folded outwards. This is also illustrated in the side view in the figure.

[0104] In step S5, the embolic protection device 1 is fully extended and pulled through the forming device 31. By further pulling on the feed unit 7, the sides of the frame 5 are pushed inwards until the entire frame is fully extended and pulled into the tube 38. The embolic protection device 1 remains inside this tube 38. The forming device 31 can now be removed from the tube 38.

[0105] In summary, it can be stated that the measures described provide an embolic protection device (1) according to the invention for delivery into an aortic arch, comprising a filter unit (3), a frame (5) and a delivery unit (7), wherein the filter unit (3) is arranged on the frame (5) and the frame (5) has a proximal region (9) which includes a proximal form (11) which is arranged in an inner region of the frame (5) and is connected to the delivery unit (7), wherein the proximal form (11) comprises a first part (13) and a second part (15), wherein the second part (15) is formed at one end of the first part (13).

[0106] In a further development of the embolic protection device (1), the first part (13) of the proximal form (11) has a first angle (W1) to the plane of the frame (5) and the second part (15) has a second angle (W2) to the first part (13) of the proximal form (11).

[0107] According to the invention, an embolic protection device (1) for delivery into an aortic arch is provided, comprising a filter unit (3), a frame (5) and a delivery unit (7), wherein the filter unit (3) is arranged on the frame (5) and the frame (5) has a proximal region (9) comprising a proximal form (11) which is arranged in an inner region of the frame (5) and is connected to the delivery unit (7), wherein the proximal form (11) comprises a first part (13) and a second part (15), wherein the first and second part (13, 15) are arranged to each other in such a way that they form a spring mechanism.

[0108] In a further development of the embolic protection device (1) the proximal form (11) can be energized via the feed unit (7).

[0109] In a further development of the embolic protection device (1), the proximal form (11) comprises two ends (17, 19) of the frame (5) which extend parallel to each other in the interior of the frame (5).

[0110] In a further development of the embolic protection device (1) the proximal form (11) is connected to the feed unit (7), wherein the two ends (17,19) of the frame (5) are wrapped by a wire (6) the ends (10) of which are arranged parallel to the ends (17, 19) of the frame (5).

[0111] In a further development of the embolic protection device (1), the frame (5) has a distal area (2) which includes a distal form (4) which is arranged in an inner area of ​​the frame (5).

[0112] In a further development of the embolic protection device (1) the distal form (4) has a constriction (12) directed towards the interior of the frame (5).

[0113] According to the invention, the connection between the frame (5) and the filter unit (3) of the embolization device is realized by means of an adhesive tunnel or an adhesive tunnel connection.

[0114] In a further development of the embolic protection device (1), the filter unit (3) is connected to the frame (5) outside the proximal and / or distal area (9, 2).

[0115] In a further development of the embolic protection device (1) the filter unit (3) is connected to the frame (5) in the distal area (2) essentially up to the beginning of the distal form (4).

[0116] In a further development of the embolic protection device (1) the filter unit (3) in the proximal area (2) is essentially connected to the frame (5) up to the first part (13) of the proximal form (11).

[0117] In a further development of the embolic protection device (1) the filter unit (3) is flexibly connected to the frame (5) in the distal and proximal areas (2, 9).

[0118] In a further development of the embolism protection device (1), the frame (5) is connected to the filter unit (3) in a transverse preload.

[0119] In a further development of the embolism protection device (1) the filter unit (3) has a projection (14) over the frame (5).

[0120] In a further development of the embolic protection device (1), the supernatant (14) is sealed.

[0121] In a further development of the embolism protection device (1), the protrusion (14) is designed as a sealing lip.

[0122] In a further development of the embolism protection device (1) in the proximal and / or distal area (9, 2) of the frame (5) the filter unit (3) is folded over the frame (5) from the underside to the top side.

[0123] In a further development of the embolic protection device (1), the filter unit (3) is attached to the distal form (4) by means of a thread, wire or yarn.

[0124] In a further development of the embolic protection device (1), the attachment of the filter unit (3) to the distal form (4) is sealed by means of a thread, wire or yarn.

[0125] In a further development of the embolic protection device (1) the filter unit (3) is attached to the distal form (4) by means of an adhesive bond.

[0126] In a further development of the embolism protection device (1) the filter unit (3) is attached in the proximal area (9) by means of a helix.

[0127] In a further development of the embolism protection device (1), the filter unit (3) has a fiber material wherein the fibers are oriented such that they have an angle of substantially 45 degrees to a longitudinal axis of the frame (5).

[0128] In a further development of the embolic protection device (1) the frame (5) has a basic shape which is designed as an oval shape.

[0129] According to the invention, a forming device (31) for forming the embolic protection device (1) is provided for insertion into a tube, wherein a frame (5) with a filter unit (3) of the embolic protection device (1) arranged thereon is formed from an expanded state to a stretched state, comprising a one-sided flat or round opening (35), a narrowest cross-section (39) and an opposite round opening (37).

[0130] In a further development of the forming device, the flat or round opening (35) of the forming device (31) is designed such that the proximal shape (11) and / or the distal shape (4) of the frame (5) of the embolic protection device is folded outwards.

[0131] According to the invention, a method for folding the embolic protection device using the forming device is specified, comprising sliding (S1) the frame (5) of the embolic protection device in front of the flat or round opening (35) of the forming device (31), wherein the feed unit (7) is passed through the forming device (31), drawing (S3) the proximal shape (11) into the forming device (31), wherein the proximal shape (11) is folded outwards, hooking (S4) the distal shape (4) over the outer edge of the forming device (31), wherein by further pulling the distal shape (4) is folded outwards and drawn into the forming device (31).

[0132] In a further development of the process, the frame (5) is elongated by drawing it into the forming device (31).

[0133] In a further development of the method, wherein the folded proximal form (11) transfers a prestress to the frame (5) which is essentially equal to the resulting stress, the bent proximal form (11) is straightened.

[0134] The description specifies a method for unfolding the embolic protection device when the embolic protection device leaves a catheter containing it, comprising pushing the embolic protection device out of the catheter, folding the distal form (4) back into an inner area of ​​the frame (5) when a distal area (2) of the frame of the embolic protection device leaves the catheter.

[0135] Further development of the procedure includes indicating the direction of the frame (5) via one or more markers when the distal area (2) exits the catheter, the distal area (2) indicating the direction of the frame (5).

[0136] A further development of the method wherein a torsion is generated in the wire of the frame (5) by pre-bending both the distal form and the proximal form, which has a preferred direction when exiting the catheter in the direction of the bent tip of the distal form. Reference symbol list

[0137] 1 Embolic protection device 2 Distal area 3 Filter unit 4 Distal shape 5 Frame 6 Stainless steel wire 7 Feeding unit 8 Adhesive unit 9 Proximal area 10 Wire ends 11 Proximal shape 12 Constriction 13 First part 14 Projection 15 Second part 17, 19 Frame ends 20 Marker 21 Proximal filter unit 22 Distal filter unit 23 Flag 25 Catheter 27 Ostium 29 Head vessel outlets 31 Shaping device 33 Distal section 35 Flat opening 37 Round opening 38 Tube 39 Narrowest cross-section 40 Proximal section 41 Adhesive tunnel 42 Seal 43 Thread S1-S5 Process steps W1 First angle W2 Second angle

Claims

1. Embolism protection device (1) for delivery into an aortic arch, comprising a filter unit (3), a frame (5) and a supply unit (7), wherein the filter unit (3) is connected to the frame (5), and the frame (5) has a proximal region (9), which comprises a proximal mould (11), which is arranged in an inner region of the frame (5) and is connected to the supply unit (7), the proximal mould (11) comprising a first part (13) and a second part (15), the second part (15) being formed at one end of the first part (13), characterised in that the connection of the frame (5) and the filter unit (3) is realised by means of an adhesive tunnel or an adhesive tunnel connection.

2. Embolism protection device (1) according to claim 1, characterised in that the first part (13) of the proximal mould (11) has a first angle (W1) with respect to the plane of the frame (5), and the second part (15) has a second angle (W2) with respect to the first part (13) of the proximal mould (11).

3. Embolism protection device (1) for delivery into an aortic arch, comprising a filter unit (3), a frame (5) and a supply unit (7), wherein the filter unit (3) is connected to the frame (5), and the frame (5) has a proximal region (9), which comprises a proximal mould (11), which is arranged in an inner region of the frame (5) and is connected to the supply unit (7), the proximal mould (11) comprising a first part (13) and a second part (15), the first and second parts (13, 15) being arranged with respect to one another in such a way that they form a spring mechanism, characterised in that the connection of the frame (5) and the filter unit (3) is realised by means of an adhesive tunnel or an adhesive tunnel connection.

4. Embolism protection device (1) according to one of claims 1-3, characterised in that the proximal mould (11) can be energised via the supply unit (7).

5. Embolism protection device (1) according to any of the preceding claims, characterised in that the proximal mould (11) comprises two ends (17, 19) of the frame (5), which extend parallel to one another in the inner region of the frame (5).

6. Embolism protection device (1) according to any of the preceding claims, characterised in that the frame (5) has a distal region (2), which comprises a distal mould (4), which is arranged in an inner region of the frame (5).

7. Embolism protection device (1) according to claim 6, characterised in that the distal mould (4) has a constriction (12) directed towards the interior of the frame (5).

8. Embolism protection device (1) according to any of the preceding claims, characterised in that the filter unit (3) is connected to the frame (5) outside the proximal region (9) and / or distal region (2) according to claim 6 and / or 7.

9. System comprising an embolism protection device (1) according to any of the preceding claims and a moulding device (31) for forming the embolism protection device (1) for drawing into a hose (38), characterised in that a frame (5) with a filter unit (3) of the embolism protection device (1) arranged thereon is formed from an expanded state into a stretched state, comprising a flat or round opening (35) on one side, a narrowest cross-section (39) and an opposite round opening (37).

10. System according to claim 9, wherein the flat or round opening (35) of the moulding device (31) is designed such that the proximal mould (11) and / or the distal mould (4) according to claim 6 and / or 7 of the frame (5) of the embolism protection device is folded outwards.

11. Method for folding the embolism protection device according to one of claims 1-8 by means of the moulding device from the system according to one of claims 9-10, comprising pushing (S1) the frame (5) of the embolism protection device in front of the flat or round opening (35) of the moulding device (31), wherein the supply unit (7) is guided through the moulding device (31), drawing (S3) the proximal mould (11) into the moulding device (31), wherein the proximal mould (11) is folded outwards, hooking (S4) the distal mould (4) over the outer edge of the moulding device (31), wherein the distal mould (4) is folded outwards and drawn into the moulding device (31) by further pulling.

12. Method according to claim 11, wherein the folded proximal mould (11) transfers a preload to the frame (5) that is substantially equal to the load resulting from straightening the bent proximal mould (11).

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